FDA Lifts Partial Clinical Hold On Gilead's MDS, AML Magrolimab Studies


The FDA has lifted the partial clinical hold on Gilead Sciences Inc's GILD studies evaluating magrolimab combined with azacitidine. 

  • The FDA removed the partial clinical hold after reviewing the comprehensive safety data from each trial.
  • The company can resume enrollment in the U.S with the magrolimab combo studies in myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML). 
  • Gilead plans to re-open enrollment in the magrolimab studies placed on a voluntary hold outside of the U.S. 
  • Related: FDA Puts Clinical Hold On Gilead's Magrolimab/Azacitidine Combo Trials In Blood Cancer Settings.
  • The company is also working with the FDA regarding the remaining partial clinical hold affecting studies evaluating magrolimab in diffuse large B-cell lymphoma and multiple myeloma. 
  • The ongoing clinical studies evaluating magrolimab in solid tumors were not subject to the clinical hold.
  • Before the clinical trial hold, Gilead had already met the pre-specified enrollment threshold required for the first interim analysis of the ENHANCE study. 
  • Gilead reaffirmed the readout schedule for the first interim analysis for 2023.
  • Price Action: GILD shares are up 0.13% at $61.97 in pre-market on the last check Tuesday.
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Posted In: BiotechNewsHealth CareFDAGeneralacute myeloid leukemiaBriefsClinical Holds
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